NCT05833152

Brief Summary

To explore the relationship between different knee extension hysteresis angles and functional outcome of knee joint after total knee replacement

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2023

Enrollment Period

1.1 years

First QC Date

April 17, 2023

Last Update Submit

May 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • WOMAC

    Knee functional scale

    three months after surgery

Secondary Outcomes (2)

  • Thickness of vastus medialis muscle

    three months after surgery

  • range of motion

    three months after surgery

Study Arms (4)

<5°

Procedure: total knee arthroplasty

5-10°

Procedure: total knee arthroplasty

10-15°

Procedure: total knee arthroplasty

≥15°

Procedure: total knee arthroplasty

Interventions

To observe the postoperative functional outcome of patients with knee extension lag at different angles

10-15°5-10°<5°≥15°

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the Department of Orthopaedics of Peking University Third Hospital for total knee arthroplasty

You may qualify if:

  • (1) Patients who meet the diagnostic criteria of knee osteoarthritis (age \>45 years old); (2) Patients admitted to the Department of Orthopedics of the Third Hospital of Beijing Medical University and preparing to receive TKA surgery; (3) The patient has good cognitive function and good compliance, and can cooperate with various examinations; (4) Voluntarily participate in the study and sign the informed consent;

You may not qualify if:

  • (1) Patients with lower extremity fracture and severe lumbar spinal stenosis that affect postoperative functional recovery; (2) Patients with severe cerebrovascular disease who cannot cooperate with postoperative rehabilitation exercise; (3) The time interval of double knee replacement was less than 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

Related Publications (1)

  • McGinn TL, Etcheson JI, Gwam CU, George NE, Mohamed NS, Mistry JB, Ananaba U, Bhave A. Short-term outcomes for total knee arthroplasty patients with active extension lag. Ann Transl Med. 2018 Jun;6(11):204. doi: 10.21037/atm.2018.05.38.

    PMID: 30023367BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Yang yanyan

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

April 27, 2023

Study Start

May 1, 2023

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

June 3, 2025

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations